Low-Fat Diet for Female Infertility

(LFD Trial)

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Reproductive hormones

Disqualifiers: Pregnancy, High HbA1C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a low-fat diet can boost reproductive hormones in women with obesity. Participants will follow a specially customized diet for one month to determine its effect on hormone levels. Women suitable for this trial have regular menstrual cycles and no history of chronic diseases affecting hormones. As an unphased trial, this study allows participants to contribute to groundbreaking research on diet and hormone health.

Do I have to stop taking my current medications for the trial?

Yes, you must stop taking any reproductive hormones or medications/supplements that impact them at least 3 months before joining the trial.

What prior data suggests that this low-fat diet is safe for women with obesity?

Research has shown that a low-fat diet can safely improve fertility in women with obesity. Studies suggest that this diet might increase reproductive hormones without requiring weight loss. Importantly, no major reports of harmful effects have emerged from following a low-fat diet in these situations.

Other studies have found that most people tolerate these dietary changes well, although some might find the diet more comfortable than others. Overall, a low-fat diet is considered a safe way to potentially enhance fertility. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using a low-fat diet to address female infertility because it offers a non-invasive and natural approach compared to standard medical treatments like hormone therapies or IVF. Unlike those treatments, which often involve medications or complex procedures, a low-fat diet can be easily customized and integrated into a person's daily routine without significant side effects. Moreover, by focusing on dietary changes, this approach might improve overall health and fertility through a more holistic method.

What evidence suggests that a low-fat diet might be an effective treatment for female infertility?

Studies have shown that a low-fat diet might improve fertility in women with obesity. Research indicates that women who eat healthily, including low-fat foods, often experience fewer fertility problems. One study suggested that switching to a low-fat diet could boost fertility for these women, even without weight loss. These dietary changes are linked to improved levels of reproductive hormones, which are crucial for having children. Overall, evidence supports the idea that a low-fat diet could benefit women facing infertility issues. Participants in this trial will follow a customized, eucaloric low-fat diet for one month to evaluate its effects on fertility. ^{2 4 6 7 8}

Who Is on the Research Team?

Nanette Santoro, MD

Principal Investigator

University of Colorado School of Medicine

Are You a Good Fit for This Trial?

This trial is for women with obesity who have regular menstrual cycles, normal reproductive hormone levels, and no chronic diseases affecting hormones. They must not be pregnant or planning pregnancy soon, use reliable contraception, and currently not on any hormonal treatments.

Inclusion Criteria

I haven't used hormones or related supplements in the last 3 months.

My ovarian reserve is normal, with an AMH level of 0.5ng/ml or higher.

Normal TSH and prolactin

Exclusion Criteria

Pregnancy or planned pregnancy within next 6 months at time of screening

HbA1C >6.5%

Baseline dietary assessment indicative of 28% or less daily calories from fat

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-diet Cycle

Participants undergo a pre-diet cycle where no specific diet is consumed

1 month

1 visit (in-person) for baseline measurements

On-diet Cycle

Participants consume a customized, eucaloric low-fat diet

1 month

1 visit (in-person) for diet monitoring and blood draw

Post-diet Cycles

Participants undergo two post-diet cycles to monitor changes in reproductive hormones

2 months

2 visits (in-person) for follow-up measurements and blood draws

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Low-fat diet

Trial Overview The study is testing whether a eucaloric low-fat diet can increase reproductive hormones in obese women. Participants will follow this specific diet to see if it affects their hormone levels without changing their calorie intake.

How Is the Trial Designed?

Group I: Low-Fat Diet Experimental Treatment 1 Intervention

Participants will eat a customized, eucaloric low-fat diet for one month

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12586016/

Diet and female fertility: a population-based study re ... We report lower odds of fertility problems with consumption of a healthy diet, whether reflected by lower dietary inflammatory potential, ...

2. news.cuanschutz.edu news.cuanschutz.edu/news-stories/could-eating-a-low-fat-diet-improve-fertility-for-women-with-obesity

Could Eating a Low-Fat Diet Improve Fertility for Women ... “The study suggests that women with obesity may be able to improve their fertility just by going on a low-fat diet, without needing to lose a ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2808489

Women's Adherence to Healthy Dietary Patterns and ... Adherence to preconception healthy dietary patterns before infertility treatment may be associated with a lower likelihood of pregnancy loss.

4. mdpi.com mdpi.com/2072-6643/17/18/2930

Prospective Observational Case Series in Infertile Women ... Results: Of 52 women enrolled, 40 initiated the VLCKD; 27 (68%) achieved ≥10% weight loss while preserving lean mass. Eleven conceived naturally during or after ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2475299122105469

Dietary Energy Density and Fertility: Results from the ... This study evaluated associations between dietary energy density and the probability of conceiving clinical pregnancy, having a live birth, and the time to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8634384/

Female Fertility and the Nutritional Approach: The Most ... In fact, data show that a diet high in trans fats, refined carbohydrates, and added sugars can negatively affect fertility. Conversely, a diet based on the ...

7. fertstert.org fertstert.org/article/S0015-0282(06)00567-X/fulltext

Effect of a very-low-calorie diet on in vitro fertilization ... A low-calorie diet in a group of overweight or obese patients for a short period before and during IVF results in variable tolerance to the dietary regime.

8. nutritionj.biomedcentral.com nutritionj.biomedcentral.com/articles/10.1186/s12937-021-00757-7

Female dietary patterns and outcomes of in vitro fertilization ... In a study conducted in China, Sun (2019) observed that clinical pregnancy rates in a high versus low adherence group was 42.62% vs. 50.94% and ...